THE CUSTOMER REPORTS THAT A SERUM BLOOD SAMPLE TAKEN 24 HOURS AFTER THE ADMINISTRATION OF METHOTREXATE TO A LEUKEMIA PATIENT WAS DIVIDED INTO TWO ALIQUOTS (PER CUSTOMER'S PROTOCOL) AND TESTED WITH THE TDX/TDXFLX METHOTREXATE II ASSAY ON A TDX/FLX ANALYZER. THE FIRST ALIQUOT GENERATED A RESULT OF 1.11 UMOL/L AND WAS REPORTED FROM THE LAB. IT WAS NOTED THAT NO CONTROL SAMPLES WERE RUN FOR THE ASSAY ON THIS DAY AND THAT THE BUFFER SOLUTION WAS REPLACED BUT WAS NOT FLUSHED THROUGH THE INSTRUMENT BEFORE TESTING. THE FOLLOWING DAY, THE SECOND ALIQUOT WAS TESTED AND GENERATED A RESULT OF 273 UMOL/L. THERE WAS NO VOLUME LEFT AFTER THESE RESULTS WERE GENERATED FOR ANY SAMPLE RETESTING. A SECOND SAMPLE WAS OBTAINED 48 HOURS POST DRUG ADMINISTRATION AND GENERATED RESULTS OF 1.70 AND 1.72 UMOL/L. CONTROLS WERE RUN AND WERE WITHIN SPECIFICATION ON THIS DAY. THE PATIENT'S ONCOLOGIST QUESTIONED THESE RESULTS IN COMPARISON TO THE RESULT OF 1.11 UMOL/L AS HE WAS EXPECTING A DROP IN THE DRUG CONCENTRATION. THE OUTCOME OF THIS ISSUE IS THAT THERE WAS A DELAY IN ADMINISTERING CALCIUM FOLINATE BY 12 HOURS TO THE PATIENT AFTER THE METHOTREXATE THERAPY. UREA NITROGEN AND CREATININE LEVELS TAKEN DID NOT INDICATE ANY KIDNEY FAILURE. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.
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Patient 1
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).
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Patient 1
THERE WERE NO RETURNS AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. ACCURACY TESTING WAS PERFORMED USING RETAINED REAGENTS OF LOT 39298M500. THREE DIFFERENT CONTROL LEVELS WERE TESTED ACROSS THREE DIFFERENT ANALYZERS. ALL RESULTS MET SPECIFICATIONS. THE ASSAY IS PERFORMING AS INTENDED. THE TDX/TDXFLX METHOTREXATE II REAGENT ASSAY PACKAGE INSERT AND THE TDXFLX SYSTEM OPERATIONS MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED AS THE INCIDENT WAS ISOLATED TO A DISCREET PATIENT SAMPLE. HUMAN ERROR MAY HAVE CAUSED OR CONTRIBUTED TO THE PRESENT EVENT.